富士胶片将投资超过20亿美元在美国建立
新的生物制药大规模细胞培养生产基地 ▉
从药物原液到灌封装和包装的端到端一站式生物药CDMO业务解决方案
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东京,2021年1月7日——富士胶片集团(总裁:Kenji Sukeno)为加速其生物制药合同开发和制造业务(CDMO)的增长,投资超20亿美元准备在美国建立一个新的大规模细胞培养生产基地。
FUJIFILM Diosynth Biotechnologies是富士胶片集团的子公司,在美国和英国设有研发和生产设施,在丹麦也将运营新设施。该新设施将提供8个2万升生物反应器(物理体积)的大规模原液细胞培养生产,并根据市场需求进一步扩大和增加24个2万升生物反应器。除了生物药原液生产,该工厂还将提供商业规模的自动化灌装和组装、包装和贴标签服务。新厂址将建在富士胶片现有厂址附近,计划于2025年春开始运营。
“美国是世界上最大的生物制药市场。我很高兴通过在美国的大笔投资,我们能够持续支持新药的开发和生产,帮助满足未被满足的医疗需求。”富士胶片公司总裁Kenji Sukeno说,“富士胶片将继续利用我们的尖端技术和先进设施,为人类健康和医疗保健行业的进步提供稳定的高品质生物制药供应。”
为了加强和发展生物CDMO的端到端服务,富士胶片正在积极投资。最近(2020年6月),富士胶片集团在FUJIFILM Diosynth Biotechnologies的Hillerød丹麦工厂投资9.28亿美元,将其大规模细胞培养生产能力翻倍,并增加商业规模生物药制剂生产能力。
FUJIFILM Diosynth Biotechnologies的首席执行官Martin Meeson表示:“我们正在利用我们的优势开发和制造各种生物制药产品,如抗体、重组蛋白、基因疗法和疫苗。我们在支持客户供应链需求方面处于独特的地位,提供从小规模到大规模生物药原液生产,直至灌装和最终包装的端到端服务。”
富士胶片设定了一个目标,到2025年3月为止,其生物CDMO业务的年收入将达到2000亿日元。在截至2026年3月的财年之后,富士胶片预计,此次投资将使其生物CDMO业务的年增长率达到20%,大大超过市场预期。展望未来,富士胶片将继续为医疗保健行业提供稳定的高质量药品供应。
*Bio-CDMO业务为生物制药和小分子制药提供服务。
新址概览
1. 地点
在现有的富士胶片公司厂址附近
2. 总投资
超过20亿美元
3. 设施
原料药生产线
·用于哺乳动物细胞的8个20000L生物反应器
罐装系统
·全自动灌装系统
包装线
·一种用于装配各种注射器和用于自动包装和贴标的设备的装置
4. 开始运营
2025年春
关于富士胶片
富士胶片是富士胶片控股公司的经营公司。日本东京富士胶片控股有限公司凭借其在不断追求创新的过程中积累的丰富知识和基础技术,为全球各行各业带来尖端的解决方案。其专有的核心技术为医疗保健、图形系统、高功能材料、光学设备、数字成像和文档产品等多个领域做出了贡献。这些产品和服务基于其广泛的组合化学、机械、光学、电子和成像技术。截至2020年3月31日的财年,该公司的全球营收为210亿美元,当时日元兑美元汇率为109日元。富士胶片致力于负责任的环境管理和良好的企业公民意识。更多信息,请访问: www.fujifilmholdings.com
FUJIFILM Diosynth Biotechnologies是一个行业领先的生物制剂合同开发和生产组织(CDMO),位于英国Teesside、北卡罗莱纳RTP、德克萨斯College Station和丹麦Hillerød。FUJIFILM Diosynth Biotechnologies在重组蛋白、疫苗、单克隆抗体、大分子、病毒产品和多种微生物、哺乳动物和宿主/病毒系统中表达的医疗对策的开发和制造方面拥有超过30年的经验。该公司提供全面的服务清单,从使用其专有的pAVEway 微生物和Apollo X细胞系系统进行细胞系开发,到工艺开发、分析开发、临床和FDA批准的商业化生产。更多信息请访问:www.fujifilmdiosynth.com
Fujifilm to Invest Over 200 Billion yen (2 Billion USD) to Establish New Large-Scale Cell Culture Manufacturing Site for Biopharmaceuticals in the U.S.A.
End-to-End Single-Site Solution from Drug Substances to Fill-Finish Packaging of its Bio CDMO Business
TOKYO, January 7, 2021 — FUJIFILM Corporation (President: Kenji Sukeno) is making an investment of more than 200 Billion yen (2 Billion USD) to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business (CDMO).
FUJIFILM Diosynth Biotechnologies, a subsidiary of FUJIFILM Corporation, with development and manufacturing facilities across the U.S.A., U.K., and Denmark will operate the new facility. This new facility will offer large-scale cell culture manufacturing of bulk drug substance with 8 x 20,000L bioreactors (physical volume), with the potential to expand and add a further 24 x 20,000L bioreactors based on market demand. In addition to drug substance manufacture, the facility will also provide commercial scale, automated fill-finish and assembly, packaging and labeling services. The new site will be built within the vicinity of an existing Fujifilm site, and is scheduled to begin operations in the spring of 2025.
“The United States is the world s biggest market for biopharmaceuticals. I am pleased that through this large investment in the U.S.A we are able to support the development and manufacturing of new drugs that can help fulfill unmet medical needs”, said Kenji Sukeno, president of FUJIFILM Corporation. “Fujifilm will continue to promote human health and support the progress of the healthcare industry by using our cutting-edge technology and advanced facilities to provide a stable supply of high quality biopharmaceuticals.”
Fujifilm is actively investing to enhance and grow its end-to-end service offerings across all of its Bio CDMO sites. Most recently (June 2020), FUJIFILM Corporation invested 100 billion yen (928 million USD) in FUJIFILM Diosynth Biotechnologies Hillerød, Denmark site to double its large-scale cell culture manufacturing capacity and add commercial scale drug product production capabilities.
“We are leveraging our strengths in process development and manufacturing for a wide range of biopharmaceuticals such as antibodies, recombinant proteins, gene therapies and vaccines,” said Martin Meeson, chief executive officer at FUJIFILM Diosynth Biotechnologies. “We are uniquely placed to support our customer supply chain needs providing end-to-end services from small to large scale bulk drug substance production, through to fill-finish and final packing.”
Fujifilm has set a target to achieve an annual revenue of 200 billion yen for its Bio CDMO business* by fiscal year ending March 2025. Beyond fiscal year ending March 2026, Fujifilm expects this latest investment to boost the annual growth rate of its Bio CDMO Business to 20%, greatly exceeding market projections. Going forward, Fujifilm will continue to contribute to the healthcare industry by providing a stable supply of high quality pharmaceuticals.
*Bio-CDMO business offers services for biopharmaceuticals and small molecule pharmaceuticals.
Overview of New Site
1. Location
United States, in the vicinity of an existing Fujifilm site
2. Total investment
More than 200 billion yen (2 billion USD)
3. Facilities
Drug substance production line
8 x 20,000L bioreactors for mammalian cells
Fill-finish line
Fully automated fill-finish system
Packaging line
A device for assembling a variety of syringes and equipment for automatic packaging and labeling
4. Operation start
Spring 2025
About Fujifilm
FUJIFILM Corporation is an operating company of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, Tokyo, Japan, brings cutting edge solutions to a broad range of global industries by leveraging its depth of knowledge and fundamental technologies developed in its relentless pursuit of innovation. Its proprietary core technologies contribute to the various fields including healthcare, graphic systems, highly functional materials, optical devices, digital imaging and document products. These products and services are based on its extensive portfolio of chemical, mechanical, optical, electronic and imaging technologies. For the year ended March 31, 2020, the company had global revenues of $21 billion, at an exchange rate of 109 yen to the dollar. Fujifilm is committed to responsible environmental stewardship and good corporate citizenship. For more information, please visit: www.fujifilmholdings.com
FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerød, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. The company offers a comprehensive list of services from cell line development using its proprietary pAVEway microbial and Apollo X cell line systems to process development, analytical development, clinical and FDA-approved commercial manufacturing. FUJIFILM Diosynth Biotechnologies is a partnership between FUJIFILM Corporation and Mitsubishi Corporation. For more information, go to: www.fujifilmdiosynth.com